BEUDAMED
    FDA Adverse Event Death Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 152914 · Received February 23, 1998

    Report

    Report Number
    2248146-1998-00175
    Event Type
    Death
    Date Received
    February 23, 1998
    Report Date
    February 12, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LABEL CODE FOR F10. POSITION 1: 1738 DEVICE LABEL CODE FOR F10. POSITION 2: 1738 DEVICE LABEL CODE FOR F10. POSITION 3: -

    Description of Event or Problem · 1

    EVENT: (CC# 98-00181) THE DR WAS UNABLE TO ADVANCE THE IAB INTO THE SHEATH AND THE IAB WAS REMOVED. ANOTHER IAB WAS INSERTED USING A LARGER SHEATH. (MULTIPLE EVENT TO CUSTOMER COMPLAINT NUMBER 98-00180) THE FOLLOWING WAS REPORTED TO DATASCOPE ON 3/30/1998: THE PT WAS BROUGHT TO CARDIOVASCULAR LAB WITH AAMI. THE IAB WAS PLACED WITHOUT USING A SHEATH. BLOOD WAS NOTICED TO BE OOZING AROUND THE INSERTION SITE. THE BALLOON WAS REMOVED AND AN 11 INCH SHEATH WAS PLACED INTO THE PT. AT THIS TIME IT WAS NOT POSSIBLE TO PLACE THE SAME IAB THROUGH THE SHEATH. THE IAB AND SHEATH WERE REMOVED. ANOTHER IAB AND LARGER SHEATH WERE USED. WHEN AN ATTEMPT WAS MADE TO PASS THE IAB THROUGH THE SHEATH OUTSIDE THE PT, IT WAS UNSUCCESSFUL. AS A RESULT OF THE EVENT ON 2/12/1998, A LARGER FEMORAL HEMATOMA FORMED AT THE INSERTION SITE. THE PT WAS ON HEPARIN AND WAS THROMBOLYTIC. THE PT EXPIRED ON 2/14/1998 FROM CONGESTIVE HEART FAILURE. THE PT'S COMPLICATIONS WERE A RESULT OF THE IAB EVENT. [EVENT COMPLICATIONS]: UNKNOWN-RPT'D 2/12/1998; FEMORAL HEMATOMA/DEATH - RPT'D 3/30/1998. [PT'S CURRENT STATUS]: EXPIRED - RPT'D 2/12/1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT DL 9.5 FR. 40 CC. IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORP. 0684-00-0283 1/18/00

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death